Actively Recruiting
ACTengine® IMA203 Combined With mRNA-4203
Led by Immatics US, Inc. · Updated on 2026-01-08
15
Participants Needed
4
Research Sites
209 weeks
Total Duration
On this page
Sponsors
I
Immatics US, Inc.
Lead Sponsor
M
ModernaTX, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This purpose of this clinical trial is to evaluate the safety, tolerability and anti-tumor activity of IMA203 in combination with different doses of mRNA-4203. The trial includes participants with previously treated unresectable or metastatic cutaneous melanoma (CM) or synovial sarcoma (SS).
CONDITIONS
Official Title
ACTengine® IMA203 Combined With mRNA-4203
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologically confirmed and documented cutaneous melanoma or synovial sarcoma with unresectable or metastatic disease
- Positive for HLA-A*02:01
- Adequate selected organ function per protocol
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Measurable disease according to RECIST 1.1
- Life expectancy more than 5 months
- Cutaneous melanoma participants must have disease progression on or after at least one PD-1 inhibitor
- Synovial sarcoma participants must have received or declined at least one line of treatment and still need further systemic therapy
- Female participants of childbearing potential must use adequate contraception prior to trial entry until 12 months after IMA203 infusion and 15 days after last mRNA-4203 dose
You will not qualify if you...
- History of other malignancies within the last 3 years except treated basal or squamous cell carcinoma or carcinoma in situ
- Pregnant or breastfeeding
- Serious autoimmune disease
- History of cardiac conditions as per protocol
- Prior allogenic stem cell transplantation or solid organ transplantation
- Concurrent severe or uncontrolled medical disease that may compromise study participation
- History of hypersensitivity to cyclophosphamide, fludarabine, IL-2, or mRNA-based medicines
- Positive for HIV infection or active hepatitis B or C infection
- Any condition contraindicating leukapheresis
- Lactate dehydrogenase (LDH) above protocol allowed threshold
- Active brain metastases prior to lymphodepletion
- Concurrent treatment in another clinical or device trial that may interfere
- Renal impairment with reduced bone marrow reserve per protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
University of California San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
2
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
3
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
4
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
I
Immatics US, Inc.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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